New neurotrophic keratitis drug closer to EU approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of cenegermin (Oxervate) for the treatment of moderate or severe neurotrophic keratitis in adults.

Designated as an orphan drug since 2015, cenegermin is a recombinant form of human nerve growth factor that stimulates corneal healing and restores ocular surface integrity. The topical drops are produced by Italian-based Dompé Pharmaceuticals.

The recommendation follows data from 2 phase II clinical trials which included 204 neurotrophic keratitis patients. In both studies, a higher rate of patients treated with cenegermin achieved complete corneal healing after 8 weeks compared with placebo-treated patients.

The most frequent adverse reactions were eye and eyelid pain, eye inflammation, increased tearing, and foreign body sensation.

If approved by the European Commission, cenegermin would be the first orphan drug in the world authorized for this indication.